Medicaid enrollees were promised by
Governor-elect Wolf a roll back of Governor Corbett’s rejection of Medicaid
expansion under the Affordable Care Act which contains stronger mental
healthcare benefits. The Center for Medicare and Medicaid Services expects
to release guidance on how the final rule of the Mental Health Parity Addiction
and Equity Act of 2008, which requires insurers to treat physical and mental
health benefits on par, may apply to Medicaid.

The painstakingly stark
reality of brain diseases is their persistent, patient, pernicious character:
diverse, pervasive, demanding growth path of biology surrounded by political
and cultural stigma. The Unseen economic
consequence of it equates to the world’s most expensive disease with estimated
2010 cost worldwide of $2.5 trillion for 2 billion patients.

Costs mount when patients
are robbed of the ability to earn a living during their most productive years.
Veterans are impacted. Three hundred
thousand of those returning from Iraq and Afghanistan have been diagnosed with
PTSD accessing care through the Veterans Administration. Some return to private sector jobs with
private health care benefits affected by the parity law. How it goes for those
who have served us will provide a roadmap for all brain disease patients over
the next decade. Most experts agree care
must be integrated between mind and body in our research for medical answers as
well as our financing of it.

One model is being used
by One Mind, a foundation founded by
former Rhode Island Congressman Patrick Kennedy. It is focused on developing accelerated
diagnostics, treatments, preventions, and cures for brain injury and brain
disease. One Mind’s CEO, General
Chiarelli approaches the challenge by finding ways to incentivize cooperation,
sharing and collaboration amongst researchers.
“They’re putting down their competitive
instincts,” he said of the researchers, “and working together for the good of
the country.”(Politico) He was told by experts throughout the nation “it would be years, if ever, before more
advanced tests could be developed for PTS(D). So, Chiarelli directed his energies toward
expanding mental health treatment programs in war zones and on domestic bases,
and he pushed military doctors to explore the efficacy of alternative
therapies”

In USA Today on June 28, 2014, NJ
based Kennedy, and Husseini Manji, global head of neuroscience at Janssen
Research and Development, LLC, a Johnson and Johnson company, offered a three
point approach , “NIH funding of brain science via the Brain Initiative,
enforcement of the 2008 Mental Health Parity Addiction and Equity Act known as
the parity law, and coordination of effort between the for profit, not for
profit, and government sectors”.

Another
solution comes fromSenator Cory
Booker(D-NJ) and Senator Dean Heller(R-NV) who included within the veterans
reform bill of $17 billion signed into law in July 2014, an extension of a PTSD program.
Cape May veterans convinced Senator Booker not only to advocate to
extend the unemployment benefits but also to extend the $2 million funding to this proven,
effective healthcare program.

As well, Representative Tim
Murphy(R-PA) is forging bi-partisan support for HR3717, ‘Helping Families in
Mental Health Crisis Act of 2013’ , with Rep Eddie Bernice Johnson(D-Tx). The bill would create an Assistant
Secretary’s position to track spending by all federal departments on mental
healthcare. Respectively serving in
the House as the only clinical psychologist and psychiatric nurse, each brings
deep expertise attracting co-sponsors with law enforcement like Representative
Patrick Meehan.

Rachel Pruchno, an endowed
professor of medicine at Rowan University and author wrote in The Philadelphia
Inquirer, it “would make life better for people with mental illness, their
families, and society. “…More and better outpatient treatment programs would
exist, primary-care physicians would be trained to care for people with mental
illness, and behavioral-health services would improve. Parents of adult children with mental illness
would be able to talk with their child’s physicians, empowering them to help
with treatment decisions when their child is in crisis”.

Emergency rooms and jail
cells have seen rising costs and investment over the last decade rationing care
for brain disease to these growing “hot spots." Simultaneously, public-private partnerships have invested in life
sciences clusters creating value for our economy and our health through its
regulated drugs, devices, and diagnostic tools.
Governor Wolf will need to monitor whether giving broader access
explodes costs. With one in four
families affected, and with a healthcare system that rewards rationing over
collaboration, balancing accountability on costs while exploiting our assets of
innovation could provide a model for the nation who voted for split government
in hopes of progress.

The aftermath of the 2008 world economic crisis yielded a new reality of extremely short-term horizons for life sciences companies seeking venture capital for growth. BioBDx, formerly of Plymouth Meeting, PA and Westford, MA, navigated this change. Byron Hewett, CEO and Chairman, and Calvin Sumner, MD, Chief Medical Officer, continued promoting the company’s Quotient® System to physicians, mental healthcare professionals, and investors. Eventually, they found a well-matched buyer when Pearson “announced (on August 27, 2013), the acquisition of substantially all of the assets of the BioBehavioral Diagnostics Company (BioBDx), the developer and marketer of the Quotient® System, the first U.S. FDA-cleared tool for the objective measurement of hyperactivity, impulsivity and inattention as an aid in the assessment of attention deficit hyperactivity disorder (ADHD)”.

Byron Hewett of BioBDx, said, “As a part of Pearson, Quotient product development, clinical trials and commercial activities will be funded more robustly and the product will be offered to an even broader audience. This will accelerate awareness and adoption, improve efficiency of patient visits and, ultimately, raise the standard of care for ADHD. Our team has deep expertise in the diagnostic world, and we believe Pearson will benefit from that expertise in the years to come.”

“We are taking immediate steps to strengthen support for current Quotient customers and expand our outreach to healthcare professionals,” said Aurelio Prifitera, President and CEO of Pearson Clinical Assessment. “We also look forward to introducing the Quotient ADHD Test to mental health and education professionals in both clinical and school settings.”

ADHD is the most common neurobehavioral condition in children, and symptoms persist into adulthood in approximately 60 percent of cases. It affects approximately 6.7 million children and adolescents and nearly 15 million adults in the United States. ADHD makes it difficult for a person to control behavior and may have serious consequences, including failure in school, family stress and disruption, depression, problems with relationships, substance abuse, delinquency, risk for accidental injuries and job failure. Early identification and effective treatment are extremely important. As such, ADHD is a condition that is central to Pearson’s vision to meet the educational needs across a spectrum of individuals.

The Quotient ADHD Test quantifies the severity of deficits in brain functions related to the symptoms of ADHD and helps clinicians to accurately diagnose and efficiently manage the condition through repeat assessments at critical decision points. The Quotient ADHD Test is currently used in pediatric, neurology and psychiatry offices throughout the United States. (SOURCE: PRWEB)

Another unique challenge to BioBDx’s growth was the five year delay in the release of the final rule for the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act. Pete Domenici, a former U.S. senator from New Mexico, and Gordon H. Smith, a former U.S. senator from Oregon, wrote a pre-final rule release in a Washington Post op-ed piece on April 12, 2012, “In, 2008, Congress passed and President George W. Bush signed the…Act. This law, which garnered bipartisan support, requires that large group health plans and Medicaid managed-care plans provide coverage for mental or substance-use disorders on par with the coverage offered for physical ailments. But when any law is passed, the federal government must implement and enforce it to make its benefits and provisions a reality.

President Obama voted for the bill as a U.S. senator, and all indications are that he remains supportive. Yet regulatory action has stalled since 2010. The final rule that would provide clarity to the millions who have a mental illness or substance-use disorder, and to their employers, has not been issued. This has created uncertainty and confusion for employers over what they must cover and when parity applies”.

Physicians who diagnose and treat ADHD as well as those physicians who use the Quotient® System either had denied or delayed payments by insurers. Former Rhode Island Congressman Patrick Kennedy, founder of One Mind for Research and House sponsor of the law, met with BioBDx executives. Financial details regarding the impact of the law’s delayed implementation were discussed. Patrick Kennedy shared his plan to press forward on parity implementation. Within a few weeks, the tragedy at Newtown placed mental healthcare and parity firmly onto the national agenda. Hewett and Sumner discussed with Pearson Clinical Assessment’s leaders, Aurelio Prifitera, CEO, and Travis Millman, VP, New Business & Innovation Group, the impact of the law. Shortly afterward, Pearson agreed to sponsor a meeting in Washington, DC with the key patient advocacy groups who support the implementation of mental health parity. The final rule was released by the Obama administration on November 8, 2013 enabling a productive roundtable discussion in Washington DC attended by the major stakeholders sponsored by Pearson, National Alliance for Mental Illness, and Spotlight on BIO Advances generating a response to the Department of Labor’s FAQ in early January 2014.

NuPathe of Conshocken, Pennsylvania, offers a strong model of an emerging biotechnology company. Its growth path illustrates the positive impact of communication and feedback between developer and regulator during the new drug application process.

Its CEO, Jane Hollingsworth, commented after a presentation to investors at the winter conference held by BIO,“We welcome the evolution in the FDA’s approach to increasing the two-way communication regarding drug applications. Increased dialogue and interaction are always helpful and should certainly improve the regulatory process.”

In 2010, NuPathe’s initial public offering raised the company an additional $50 million, accessing more diverse capital. The IPO was motivated by NuPathe to take advantage of favorable migraine market dynamics to commercialize its migraine patch. The patient pool for the patch turns to the internet to find solutions to one of the major symptoms of migraine, considerable migraine-related nausea. Marketing the migraine patch became self-evident.

NuPathe’s website elaborates, “If approved, NP101 will be the first transdermal patch for the treatment of migraine. NP101 actively delivers sumatriptan, the most widely prescribed migraine medication. In clinical trials involving more than 10,000 applications, NP101 offered patients fast onset and sustained relief of debilitating migraine symptoms including headache pain and migraine-related nausea (MRN). It utilizes SmartRelief, our proprietary transdermal delivery technology, that rapidly transports medication through the skin using a process called iontophoresis.”

Now, the market is primed to be developed. The core patient population is both working age, 25 to 55 year old, and social media sophisticated, thus a lower percentage of NuPathe’s capital will be used to market the product than has historically been the case with many other products. Staying nimble, efficient and fast as a management team has led to NuPathe achieving the hard technical challenge of developing the transdermal technology.

The management team brings complementary skills. Jane Hollingsworth is a lawyer with deep experience in the pharmaceutical industry. Terri Sebree is a neuroscientist with a long track record of getting product candidates approved by the FDA. Their prior joint, co-founding venture at Auxilium gave them the experience to develop a model for a biotechnology company that has emphasized an industry trend: Big Pharma is partnering with biotechnology companies to fill its pipeline. NuPathe has grown slowly and surely, developing a pipeline of therapeutic candidates as well as the financial structure to support its growth. In common, Hollingsworth and Sebree have strong leadership skills and consider problem solving an important element in drug development. Also, they have been patient with the process. At this point, they have invested six years.

Where does its product stand in the regulatory process? NuPathe completed a new drug application in the fall of 2010. It received an August 2011 complete response letter from the FDA, which included additional questions about the application. As a result of a meeting with the FDA to reach an agreement about resubmission details, NuPathe will resubmit the new drug application in the next several months, starting a new clock for a six-month review.

In the closing conference session, Dr. Stephen P. Spielberg, deputy FDA commissioner, talked about the modernizing the regulatory process. “Since my career began 35 years ago in the 1960s, science has changed. We have a huge change of our understanding of biology. The innovation and the technology have created a sea change. Science is complex and at times overwhelmingly so and it has outpaced our sociology.” The challenge to do so while meeting the standards of efficacy, safety and quality impacts all stakeholders.

As the FDA application is processed, NuPathe continues to develop contacts with migraine experts, potential business development partners, and investors interested in its migraine patch, SmartRelief transdermal technology and two other product candidates using the company’s long-term biodegradable implant technology: one for Parkinson’s disease and one for schizophrenia and bipolar disorder.

And forward, the clock moves while the national BIO organization continues to work on legislative efforts in two areas – renegotiation of the fifth series of PDUFA allowing the FDA to collect fees from companies that produce human drugs and biologics to support limited FDA activities around the drug review process and the TREAT act which would create an accelerated approval pathway at the FDA for treatments for diseases or conditions that are serious or life-threatening.